Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016701404

FEI Number

3016701404

Entity Name

Philips North America LLC

City/State/Country

Export, PA, US

Establishment Address

1003 Corporate Lane, STE B, Export, PA 15632, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Philips Medical Systems International BV (Owner Number: 1217116)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IntelliVue 4-Slot Module Rack FMX-4 (866468) IntelliVue Patient Monitor MX850 (866470) IntelliVue Patient Monitor MX750 (866471) Expression MR ECG Leads, IEC, Neonatal - 989803193771 Expression MR ECG Leads, IEC, CV - 989803193751 Expression MR ECG Leads, AAMI, Neonatal - 989803193741 Expression MR Wireless SPO2 Patient module (Gen 3) 1-5 - 989803192771 Expression MR Universal Gating Interface - 989803195521 Expression MR400 MRI Patient Monitoring System (Model MR400) Expression MR Wireless ECG Patient Module (Gen 3) 6-10 - 989803194341 Expression MR ECG Leads, AAMI - 989803193721 Expression MR ECG Leads, AAMI, Standard - 989803193731 Expression MR ECG Leads, IEC, Standard - 989803193761 FlexTEMP System, Sensor - 989803178171 Expression MR Wireless ECG Patient Module (Gen 3) 1-5 - 989803192761 Expression MR IBP Transducer Cable, 5ft - 989803194601 Expression MR FlexTEMP II Sensor - 989803194511 Expression MR Wireless SpO2 Patient Module (Gen 3)6-10 - 989803194331 Expression MR400 New MRI Monitor Accessories - 866428 Philips CareEvent Application Software Version B1 CareEvent EarlyVue VS30 (863380) EarlyVue VS30 Vital Signs Monitor Avalon Fetal/Maternal Monitors FM20 (M2702A), FM30 (M2703A), FM40 (M2704A) and FM50 (M2705A) Avalon Fetal & Maternal Patch Avalon Patient Module (M2738A) Avalon CL Fetal & Maternal Pod (866488) M1911A Fetal Monitoring Recording Paper Transducers (866075, 866076, 866077, 867245, 867246, 867247, 867248, 867249, M2735A, M2736A, M2736AA) Avalon Basestation (866074) Remote Event Marker (989803143411) 989803184851- Avalon Belt Clip M1910A Fetal Monitoring Recording Paper M2734B MECG Adapter Cable (M1363A) M1913J Fetal Monitoring Recording Paper M1913A Fetal Monitoring Recording Paper IntelliVue Patient Monitors, Philips IntelliBridge EC10 and EC5 ID Module Philips MP40, MP50, MP60, MP70, MP80, MP90, AND MX800 Philips IntelliVue TcG10 Measurement Module Flex Adapter Nissha Adult Electrode Quadtrode CV MRI ECG Electrode Pad - 989803179041 40494E, Limb Clamp Electrode QUADTRODE MRI ECG PAD,25/BOX - 989803179031 Neonatal Quadtrode MRI ECG Electrode Pad - 989803179051 ePatch ECG Electrode Patch ECG Electrode MCOT Patch Patch electrode ePatch electrode 2-CH Patch Universal Patch BTP-1000P (Patch) Patch Philips ECG Comfort Patch Lead Wire Adapter Gel, ECG/EEG, Skin Prep, Tube, 3-Pack BIS Module Expression MR FlexTEMP System, Jacket - 989803178181 IntelliVue NMT Hand Adapter Philips MP2 MP5 MP5TMP5SC MP20 MP30 MP40 MP50 MP60 MP70 MP80 MP90 MX600 MX700 MX800 Intellivue Pat. Monitors IntelliVue X2 Multi-Measurement Module NMT Module (865383) NMT Patient Cable (989803174581) 867040 - IntelliVue Capnography Extension 867041 - IntelliVue Microstream Extension CANNULA,DISP,INFANT (4200F) Philips IntelliVue Information Center iX, M3290B Software Holter 1810/ 2010 SW Patient Information Center iX (PIC iX) IntelliVue Patient Monitors MX430, MX700, MX800, MP5, MP5SC Cardiac Workstation 5000 CW 5000 (860439) CW 7000 (860441) Cardiac Workstation 7000 Wireless PIM Leadwire, 3mm needle AAMI (989803223951) Wireless PIM Leadwire, 4mm banana IEC (989803223961) IntelliVue Patient Monitor MX550 (866066) IntelliVue Patient Monitor MX400 (866060) IntelliVue Patient Monitor MX450 (866062) IntelliVue Patient Monitor MX500 (866064) 867036, IntelliVue Multi-Measurement Module MMX G7m Module IntelliVue Patient Monitors MP40, MP50, MP60, MP70, MP80, MP90, MX500, MX550, MX600, MX700, MX800 CareEvent DigiTrak XT Holter Recorder w/Leadwires DL950 Holter System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-12-20
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-12-20
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2023-12-20
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-12-20
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2023-12-20
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2023-12-20
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-12-20
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-12-20
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2023-12-20
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-12-20
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2023-12-20
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2023-12-20
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2023-12-20
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-12-20
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2023-12-20
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-12-20
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-12-20
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-12-20
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2023-12-20
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-12-20
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2023-12-20
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-12-20
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2023-12-20
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-12-20
GWS	Analyzer, Spectrum, Electroencephalogram Signal	Neurology	Class 1	882.1420	2023-12-20
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2023-12-20
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2016-01-11
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2016-02-26
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2019-10-30
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2019-10-30
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-10-30
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2019-10-30
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2019-10-30
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2019-10-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-10-30
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2014-12-01
HFM	Monitor, Uterine Contraction, External (For Use In Clinic)	Obstetrics/Gynecology	Class 2	884.2720	2014-12-01
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2014-12-01
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2014-12-01
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2014-12-01
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2014-12-01
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2014-12-01
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2014-12-01
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2014-12-01
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2014-12-01
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2014-12-01
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2014-12-01
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2014-12-01
HGL	Transducer, Ultrasonic, Obstetric	Obstetrics/Gynecology	Class 2	884.2960	2014-12-01
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Cardiovascular	Class 2	870.2780	2014-12-01
DXQ	Blood Pressure Cuff	Cardiovascular	Class 2	870.1120	2014-12-01
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2014-12-01
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2014-12-01
HFN	Transducer, Pressure, Intrauterine	Obstetrics/Gynecology	Class 2	884.2700	2014-12-01
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2014-12-01
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2013-07-03
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2013-07-03
LPP	Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2013-07-03
DRX	Electrode, Electrocardiograph	Cardiovascular	Class 2	870.2360	2022-02-23
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	Class 2	882.1400	2009-10-29
OLW	Index-Generating Electroencephalograph Software	Neurology	Class 2	882.1400	2009-10-29
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2009-10-29
OMC	Reduced- Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2009-10-29
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2013-08-19
GWR	Generator, Electroencephalograph Test Signal	Neurology	Class 1	882.1430	2012-08-31
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2012-08-31
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2012-08-31
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2012-08-31
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2012-08-31
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2012-08-31
DRJ	System, Signal Isolation	Cardiovascular	Class 1	870.2600	2012-08-31
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2012-08-31
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2012-08-31
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2012-08-31
KRB	Probe, Thermodilution	Cardiovascular	Class 2	870.1915	2012-08-31
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2012-08-31
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2012-08-31
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2012-08-31
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2012-08-31
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2012-08-31
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2012-08-31
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2012-08-31
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2012-08-31
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2012-08-31
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2012-08-31
DRS	Transducer, Blood-Pressure, Extravascular	Cardiovascular	Class 2	870.2850	2012-08-31
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2012-08-31
DRW	Adaptor, Lead Switching, Electrocardiograph	Cardiovascular	Class 2	870.2350	2012-08-31
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2012-08-31
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2012-08-31
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2012-08-31
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2012-08-31
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2012-08-31
MLC	Monitor, St Segment	Cardiovascular	Class 2	870.2340	2012-08-31
KRC	Tester, Electrode, Surface, Electrocardiographic	Cardiovascular	Class 2	870.2370	2012-08-31
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2012-08-31
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2012-08-31
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2012-08-31
GWS	Analyzer, Spectrum, Electroencephalogram Signal	Neurology	Class 1	882.1420	2012-08-31
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2012-08-31
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2012-08-31
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2012-08-31
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2012-08-31
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2018-01-11
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-01-11
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2018-01-11
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2018-01-11
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2018-01-11
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2018-01-11
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-05-30
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2016-02-26
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Cardiovascular	Class 2	870.2800	2016-02-18
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2019-10-15
DSH	Recorder, Magnetic Tape, Medical	Cardiovascular	Class 2	870.2800	2019-10-15
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2019-10-15
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2019-10-15
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2019-10-15
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2019-10-15
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2019-11-21
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2019-11-21
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2019-11-21
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2019-11-21
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2019-11-21
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2019-11-21
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2019-11-21
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2019-11-21
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2024-12-20
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-08-23
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2023-08-23
KLK	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia	Anesthesiology	Class 2	868.2500	2023-08-23
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2023-08-23
BZC	Calculator, Pulmonary Function Data	Anesthesiology	Class 2	868.1880	2023-08-23
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-08-23
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2023-08-23
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2023-08-23
DSF	Recorder, Paper Chart	Cardiovascular	Class 1	870.2810	2023-08-23
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2023-08-23
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2023-08-23
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2023-08-23
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2023-08-23
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	Class 2	868.2775	2023-08-23
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-08-23
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2023-08-23
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-08-23
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-08-23
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2023-08-23
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-08-23
GWS	Analyzer, Spectrum, Electroencephalogram Signal	Neurology	Class 1	882.1420	2023-08-23
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2023-08-23
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-08-23
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-08-23
LKD	Monitor, Carbon-Dioxide, Cutaneous	Anesthesiology	Class 2	868.2480	2023-08-23
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2023-08-23
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2018-11-19
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2018-11-19
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2018-11-19
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-11-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-11-19
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2018-11-19
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2018-11-19
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2018-11-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2015-07-23
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2015-07-23
MLD	Monitor, St Segment With Alarm	Cardiovascular	Class 2	870.1025	2015-07-23
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2015-07-23
DSJ	Alarm, Blood-Pressure	Cardiovascular	Class 2	870.1100	2015-07-23
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2015-07-23
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Cardiovascular	Class 2	870.2060	2015-07-23
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2015-07-23
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2019-10-14
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2009-03-11

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Philips Medical Systems International BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K913749	Edentec Corp.	EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170	1992-07-02
K771407	Research Development Corp.	LUNG VOLUME & PRESSURE MONITOR	1977-08-04
K122223	Philips Medizin Systeme Boeblingen GmbH	NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO	2013-04-12
K893133	Mennen Medical, Inc.	HORIZON 2110/HORIZON 2210 264-XXX-XXX/261-XXX-XXX	1989-07-14
K771977	Instrumentation Laboratory CO	CARDIAC OUTPUT COMPUTER MODEL 701	1978-01-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0078-2022	Philips North America LLC	3	Philips, HeartStart FR2 + Defibrillator, Model # M3860A and M3861A
Z-0079-2022	Philips North America LLC	3	Philips, HeartStart FRx + Defibrillator, Model # Model #s: 861304
Z-0080-2022	Philips North America LLC	3	Philips, HeartStart HS1 Home Defibrillator, Model # Model number: M5068A
Z-0081-2022	Philips North America LLC	3	Philips, HeartStart HS1 OnSite Defibrillator, Model #'s: M5066A and M5067A
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016701404. Last updated year: 2026. Please use registration number 3016701404 when referencing this establishment in official correspondence.